NCT05529979

Epione® Post-Market Clinical Follow-up Study

Post-Market Clinical Follow-Up Study of a Robotic Device for Image Guided Percutaneous Needle Placement in the Abdomen

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 55 (actual)
• Sponsor: Quantum Surgical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Post-Market Clinical Follow-up study in order to consolidate performance and safety data of the EPIONE® device when used for percutaneous procedures in the abdomen

Detailed description

The objective of this PMCF study is to compile data on the routine use of the EPIONE® device in subjects undergoing CT-guided percutaneous procedures in the abdomen. The objectives are: 1. to evaluate the technical success of the device 2. to evaluate performance parameters (accuracy measures, adjustements, post-intervention ablation success, local tumor recurrence, operator satisfaction) and the safety of the device 55 patients are planned in this post-market study.

Conditions

• Cancer Abdomen

Interventions

Type	Name	Description
DEVICE	EPIONE® CT-Guided Percutaneous procedures	The EPIONE device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous procedures.

Timeline

• Start date: 2022-04-28
• Primary completion: 2023-02-22
• Completion: 2024-04-27
• First posted: 2022-09-07
• Last updated: 2026-01-06
• Results posted: 2026-01-06

Locations

1 site across 1 country: France